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Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months (GZA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01881191
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
Robert Zivadinov, MD, PhD, University at Buffalo

Tracking Information
First Submitted Date June 17, 2013
First Posted Date June 19, 2013
Last Update Posted Date February 12, 2016
Study Start Date June 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2013)
The primary aim of this study is to define the effect of teriflunomide (Aubagio®) on the development of gray matter (GM) atrophy in patients with relapsing multiple sclerosis (MS) using MRI. [ Time Frame: baseline, 6 month and 12 month ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01881191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 18, 2013)
The secondary objective of this study is to define the effect of teriflunomide on subcortical deep gray matter (SDGM) pathology using MRI over 12 months. [ Time Frame: baseline, month 6 and month 12 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months
Official Title Effect of Teriflunomide (Aubagio®) on Gray Matter Pathology in Multiple Sclerosis: The 12 Months, Prospective, Observational, Single-blinded, Longitudinal Study
Brief Summary This study will evaluate the effects of Aubagio on changes in the brain using MRI.
Detailed Description Patients who take Aubagio will have an MRI, eye test, have blood taken, and complete a questionnaire on environmental risk factors to evaluate changes in the brain and on disease progression. A healthy control group will also complete the same testing regimen.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum to be retained.
Sampling Method Non-Probability Sample
Study Population

MS patients from the Baird MS Center, The Jacobs Neurological Institute, Department of Neurology, State University at Buffalo, NY, USA who are also taking Aubagio as their disease modifying therapy.

Healthy controls from the general population.

Condition Multiple Sclerosis
Intervention Other: MRI
Study Groups/Cohorts
  • Aubagio MRI
    Patients with relapsing-remitting multiple sclerosis who take Aubagio will have an MRI, eye test, blood drawn, and complete a questionnaire.
    Intervention: Other: MRI
  • Healthy controls
    Subjects who are otherwise healthy, without neurological disorders will have an MRI, eye test, blood drawn, and complete a questionnaire.
    Intervention: Other: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 18, 2013)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects aged 18-65
  • Clinically definite MS according to the Polman criteria, 52
  • Relapsing MS or Healthy Control (no neurological disorders)
  • Expanded Disability Status Scale (EDSS) scores ≤5.5
  • Disease duration <30 years
  • Normal kidney function (creatinine clearance >59 mL/min) (patients only)
  • Signed informed consent
  • None of the exclusion criteria

Exclusion Criteria:

  • MS patients with hepatic impairment
  • Nursing mothers or pregnant women who will need to undergo 12 months follow-up
  • Women of childbearing potential not using reliable contraception
  • Patients currently treated with leflunomide
  • Serum alanine aminotransferase (ALT) >1.5 times the upper limit of normal
  • A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment
  • Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
  • Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study
  • Other pathology related to MRI abnormalities
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01881191
Other Study ID Numbers GZ-2013-10958
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Robert Zivadinov, MD, PhD, University at Buffalo
Study Sponsor University at Buffalo
Collaborators Not Provided
Investigators
Principal Investigator: Robert Zivadinov, MD,PhD,FAAN University at Buffalo
PRS Account University at Buffalo
Verification Date February 2016